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Antibiotic Use and Public Policy –
H. Scott Hurd DVM, PhD
College of Veterinary Medicine, Department of Production Animal Medicine
Iowa State University, Ames IA 50011, 515-294-7905.
Former Deputy Undersecretary for Food Safety USDA
Overview of antibiotic resistance
topics
What does the risk-based science say?
What would the future be like?
What is the problem?
Antibiotic RESISTANCE
• Exposure to
antibiotics selects
for some resistance
strains
• Human infections
with resistant strains
may be harder to
treat
Why is there a debate?
• What is acceptable risk?
• Who gains, benefits?
• Precautionary
• Risk-based vs science-based
• Non scientific political agenda
Antibiotics: Why a debate? S. 619/H.R. 1549: Policy or Politics?
What does risk-based science
say?
“Probabilistic risk assessment should be used to
reduce unnecessary conservatism
associated with current regulatory requirements …”
Nuclear Regulatory Commission (1995)
You too can do a risk assessment
• Risk = Pr (injury | wreck) = conditional
– Risk of auto accident = Pr (wreck)
• Traffic
• Road type
• Weather
• Driver skill and alertness (etc)
• Probability = a*b*c*d
Auto accident example (cont)
– Injury if in auto accident
• Speed at impact (continuous var)
• Seat belt = Y/N
• Type of collision (say 5 categories)
– Head on
– Right angles
– Glancing head on (etc)
– Safety of car (H, M, L)
– Series of conditional probabilities
Multidisciplinary
Quantitative risk assessment
Release Assessment: Describes the
probability that factors related to the
antimicrobial use in animals will result in
the emergence of resistant bacteria or
resistance determinates (RzD).
Exposure Assessment: Describes the
likelihood of human exposure to the RzD
through particular exposure pathways.
Consequence Assessment: Describes the
relationship between specified exposures
to the RzD (the hazardous agent) and the
consequences of those exposures (CVM-
defined hazard)
Pathway of Events Leading to the Risk
Risk = 1 in 10 million per year
FDA 152 methods
2. Risk Assessments have shown Risk (High to Low) Yearly Probability Outcome
Comments
Enrofloxicin use in poultry to
treat disease
1 in 30,000 Compromised treatment
By FDA, overestimated attributable
fraction
Enrofloxicin use in poultry to
treat disease
Removal is more
hazardous to health
By Cox and Popken
Being struck by lightning
1 in 550,000 Occurrence
Dying from a bee sting
1 in 6 million Death
All macrolide uses (cattle,
swine, poultry)
1 in 10 million Compromised treatment
By Hurd et al., Alban in Denmark
Streptogramin/Virginiamycin
use
~ 100 in 100 million Impaired treatment
By FDA, still a draft
Penicillin growth promoter ~4 in billion Excess mortality
Cox and Popken
Fluoroquinolone use in dairy
heifers
~1 in 61 billion Compromised treatment
Stop and Ponder Why take additional risk??
WHY? Healthy animals really do
make safer food
• Meat Inspection Act 1906
• Antemortem inspection
Largest meat
recall in U.S.
history due to
slaughter of
downer cows
February, 2008
Animal
Health
Antibiotic
Use
Herd
Management
Disease
Other
Factors
Healthy
Animals
Uncontaminated
Product
Susceptible
Humans
Sick
Humans
Processing
Discard
Trim
Sick
Animals
Contaminated
Product
Inspection
Swine Health Effects Carcass Quality
and Ultimately Human Health
Adhesions increase chance of fecal contamination!!
• “The public health
risk of unhealthy
animals is greater
than antibiotic
resistance
concerns”
SHOW ME
THE DATA!
0
20
40
60
80
100
120
0.00 5.00 10.00 15.00
Peel out percent
Perc
en
t co
nta
min
ate
d
%Campy PL pos
%Ecocc B pos
Linear (%Campy PL pos)
Linear (%Ecocc B pos)
Recent study (in press Amer J. of Vet Med Research)
• 358 carcasses were selected over four replicates
• Lesioned and non-lesioned carcasses were
identified
• Individual carcass swabs cultured for Salmonella
• Logistic regression analysis showed the
probability of Salmonella contamination in
lesioned carcasses was 90% higher than in non-
lesioned (Odds ratio = 1.9, 95% CI = 0.9-4.0)
Lesioned and non-lesioned
Pathologist score ~ 6
90% more likely to be
contaminated with
Salmonella at end of
slaughter
Pathologist score ~ 0 to 1
The Future?
FDA guidance 209
Legislation
“Consumer” groups
GAO report
CDC and public health
The Future
• More veterinary oversight
• Growth promoters?
• Better records will be required
• Legislation (federal) is doubtful
• Nuisance cases with antibiotic
resistance as part of the harm
• Continued demand for food!
• “Sustainability” concerns
FDA Guidance 209
The Judicious Use of Medically Important
Antimicrobial Drugs in Food-Producing
Animals
• Just released, June 28, 2010
• No regulatory authority
• Focus in “medically important”
antimicrobials (human therapeutic use)
• Principles, Limit to uses:
– “necessary for animal health”
– that include “veterinary oversight”
Focus on growth promotion
• In regard to animal use, this document addresses the use of
medically important antimicrobial drugs in food-producing
animals for production or growth-enhancing purposes. These
uses, referred to as production uses in this document, are often
also referred to as “nontherapeutic” or “subtherapeutic” uses.
• Unlike other uses of these drugs in animals (e.g., for the
treatment, control, and prevention of disease), these “production
uses” are not directed at any identified disease, but rather are
expressly indicated and used for the purpose of enhancing the
production of animal-derived products (e.g. increasing rate of
weight gain or improving feed efficiency).
Preserve prevention
• “…the administration of medically important
antimicrobial drugs to entire herds or flocks of
food-producing animals (e.g., for production
purposes) would represent a use that poses a
qualitatively higher risk to public health than
the administration of such drugs to individual
animals or targeted groups of animals (e.g.,
to prevent, control, or treat specific
diseases)”.
FDA guidance 209 focus
• Growth promotion label
– Must have bacteria of action
• Other the counter (OTC)
• Veterinary oversight
Definition of “oversight”
• (1) evidence of effectiveness,
• (2) evidence that such a preventive use is
consistent with accepted veterinary practice,
• (3) evidence that the use is linked to a
specific etiologic agent,
• (4) evidence that the use is appropriately
targeted, and
• (5) evidence that no reasonable alternatives
for intervention exist
What should you do?
• Fight the GOOD fight
• Do everything you can before using
antibiotics
• Use antibiotics
correctly/fully/carefully/prudently, etc
• Keep perfect records
• WHY?
Full utilization of antimicrobials is
a veterinarian’s/producer’s ethical
responsibility
• IF
• There is minimal public health risk from antibiotic use
• Healthy animals make safe food
• The world will need increasing amounts of pork
• Antimicrobials improve efficiency of production
• The government and consumers do NOT always know what is
best for the “common good”
• THEN
• We must fight for risk-based decision making
• We must use the “systems approach” to address risk-risk
concerns
• We must keep our “antibiotic use house” in perfect order
Ethics of food safety
Intensification / recalls
Sustainability
Organic
Antibiotic use Free range
Animal welfare
Local
Hormones
Animal health
Accountability
Feeding the
world